A Pivotal Trial to Assess the Safety and Clinical Efficacy of the M-001 as a Standalone Universal Flu Vaccine
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|ClinicalTrials.gov Identifier: NCT03450915|
Recruitment Status : Completed
First Posted : March 1, 2018
Results First Posted : September 13, 2021
Last Update Posted : October 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: M-001 Biological: Saline||Phase 3|
The placebo-controlled pivotal clinical efficacy Phase 3 trial plans to enroll a total of approximately 12,460 participants over two years. Participants will be immunized twice with the M-001 influenza vaccine candidate or placebo. Influenza incidence and illness severity will be evaluated throughout the follow-up period of up to two years. Participants will be 50 years and older, with at least half over 65 years of age.
The trial is expected to take place in eastern European countries and begin prior to the 2018/19 Northern Hemisphere flu season.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12460 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Experimental group: 2 immunizations with M-001 Control group: 2 injection of saline (placebo)|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||All parties are blinded except for the person who prepares the syringe for injection. The M-001 is cloudy white and its appearance is different from the transparent saline that is used for placebo. The person prepares the syringe with an opaque sticker that fully covers the syringe contents. People administering the syringe are not involved or present during syringe preparation, and are thus fully blinded.|
|Official Title:||A Pivotal Multi-center, Randomized, Modified Double-blind, Placebo-controlled Phase 3 Trial to Assess the Safety and Clinical Efficacy of M-001 Influenza Vaccine Administered Intra-muscularly Twice in Older Adults and Elderly (≥50 Years).|
|Actual Study Start Date :||August 1, 2018|
|Actual Primary Completion Date :||July 2, 2020|
|Actual Study Completion Date :||October 23, 2020|
Participants will be vaccinated with 1mg dose of M-001 twice: Once at Day 0, and once at Day 21.
A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses.
Other Name: Multimeric-001
Placebo Comparator: Saline
Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.
0.9% sodium chloride (NaCl)
- Number of Participants With qRT-PCR or Culture-confirmed Influenza-like Illness [ Time Frame: From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year ]Prevention of influenza disease by comparing the occurrence of either qRT-PCR or culture confirmed influenza in the M-001 experimental group vs. placebo caused by any influenza A or B virus in association with a protocol defined Influenza Like Illness.
- Number of Participants With One or More Serious Adverse Events, New Onset Chronic Illness, and Non-solicited Adverse Events [ Time Frame: From Day 0 to end of study completion by participant which coincides with end of flu season in the respective year, an average of 4 months per participant per year ]Number of participants with one or more Serious Adverse Events, New Onset Chronic illness, and Non-solicited Adverse Events assessed during one flu season per participant
- Number of Participants With Culture-confirmed Influenza Incidence [ Time Frame: From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year ]Occurrence of culture confirmed influenza in the M-001 experimental group vs. placebo caused by any influenza A or B virus in association with a protocol defined Influenza Like Illness.
- Number of Participants With Reduction of Severity of qRT-PCR or Culture-confirmed Influenza [ Time Frame: From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year ]Assessed by reduction of severity of either qRT-PCR or culture-confirmed influenza illness by the reduction due to M-001 in the average number of days with respiratory or systemic symptoms during the first laboratory-confirmed influenza illness episode.
- Number of Participants With Influenza-like Illness Symptoms [ Time Frame: From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year ]Assessment of number of participants having ILI symptoms in the experimental or control group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450915
|Jagiellońskie Centrum Innowacji Sp.z o.o.|
|Kraków, Ul. Bobrzyńskiego 14,, Poland, 30-348|
|Jagiellońskie Centrum Innowacji Sp.z o.o.|
|Kraków, Poland, 30348|
|Study Director:||Tamar Ben-Yedidia, PhD||BiondVax Pharmaceuticals ltd.|